A randomized equivalence clinical trial to evaluate the efficacy of an innovative, non-obturation endodontic treatment protocol “SealBio†for mature, permanent non-vital teeth as compared to conventional endodontic treatment with root canal obturation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 192
- Locations
- 1
- Primary Endpoint
- Complete control and resolution of clinical signs
Study Overview
Brief Summary
To evaluate and compare the healing response following novel, non-obturation endodontic treatment and the conventional endodontic treatment protocol by clinical and radiographic evaluation with pre and post treatment digital intra-oral X-ray and Cone Beam Computed Tomography (CBCT).xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
192 cases of at least 2 periapically infected teeth will be included in the study (Sample calculation shown in Materials and methods). Ethical clearance and informed consent of the patient will be taken. Inclusion and exclusion criteria will be laid down and followed. One of the affected teeth will be treated by conventional endodontic procedure of cleaning, shaping, disinfection, obturation and coronal seal. The other tooth will be treated by the novel treatment protocol. Pretreatment digital intraoral periapical X rays and CBCT will be taken. The cases will be followed up at 3, 6 months, 1, 1 ½ and 2 years and evaluated clinically and radiographically. Post treatment CBCT will be taken only at 6-months interval. The data will be analyzed and healing response will be compared in the two groups.
Study Design
- Study Type
- Interventional
- Allocation
- Permuted block randomization, variable
- Masking
- Open Label
Eligibility Criteria
- Ages
- 10.00 Year(s) to 90.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Cases presenting with clinical or radiographic signs and symptoms of periapical pathologies, irrespective of age and sex will be included in the study.
Exclusion Criteria
- •Patients having any systemic disease, which can compromise the healing response such as diabetes, patients on excessive medications, on immuno-suppressants, those receiving RT or CT etc.
- •will not be included.
Outcomes
Primary Outcomes
Complete control and resolution of clinical signs
Time Frame: followed up at 3, 6 months, 1, 1 ½ and 2 years
and symptoms of periapical disease, such as
Time Frame: followed up at 3, 6 months, 1, 1 ½ and 2 years
pain, swelling, inflammation and restoration of
Time Frame: followed up at 3, 6 months, 1, 1 ½ and 2 years
function
Time Frame: followed up at 3, 6 months, 1, 1 ½ and 2 years
Radiographic evidence of healing of periapical
Time Frame: followed up at 3, 6 months, 1, 1 ½ and 2 years
lesions showing disappearance or reduction in
Time Frame: followed up at 3, 6 months, 1, 1 ½ and 2 years
size of the lesion or atleast arrest of lesion size
Time Frame: followed up at 3, 6 months, 1, 1 ½ and 2 years
(not increasing)
Time Frame: followed up at 3, 6 months, 1, 1 ½ and 2 years
Secondary Outcomes
- Formation of a natural, biological seal of(mineralized tissue at the root apices)